Catalog Number

-

Brand Name

Ultra-Care Pen Needles 31G 5/16" 100 Ct

Version/Model Number

240395

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FMI

Product Code Name

Needle, Hypodermic, Single Lumen

Public Device Record Key

3a3a4acc-9e79-44b5-84e8-1333b1e3592f

Public Version Date

January 20, 2020

Public Version Number

2

DI Record Publish Date

November 29, 2018

Package DI Number

00372217006282

Quantity per Package

12

Contains DI Package

00372217006039

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case